Quantitative fluorescence-guided perfusion assessment of the anastomosis during gastrointestinal surgery

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON26683

Enrollment

199

Registered

2020-05-25

Start date

2020-06-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients that undergo FA-guided (1) esophagectomy (2) ileal pouch-anal anastomosis (IPAA), or (3) a partial or total mesorectal excision for colorectal cancer with restoration of bowel continuity will be included

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: In order to be eligible for inclusion in this study, a patient must meet all of the following criteria: - Age of 18 years and older; - Informed consent - Scheduled for one of the following options: 1. an esophagectomy for esophageal cancer with gastric conduit reconstruction; 2. proctocolectomy or completion proctectomy with IPAA for inflammatory bowel disease (IBD) or inherited colorectal cancer disorders; 3. a partial or total mesorectal excision for colorectal cancer with restoration of bowel continuity;

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded: - Allergy to ICG, iodide or sodium iodide; - Hyperthyroidism or benign thyroid tumour; - Thyroid examination using radioactive iodide <1 week; - Breast-feeding or pregnancy; - No informed consent.

Design outcomes

Primary

Measure	Time frame
The main objective of this study is to evaluate quantitative FA-parameters before and after anastomotic reconstruction, during (1) esophagectomy (2) IPAA and (3) a partial or total mesorectal excision with restoration of bowel continuity and to relate these parameters to patient outcomes, including anastomotic leakage.	—

Secondary

Measure	Time frame
The main secondary objective is to evaluate the relation between quantitative FA-parameters to hemodynamic parameters, including vitals and inotropic or vasopressive drug use. Other secondary objectives include measuring differences in quantitative FA-parameters with different distances to the anastomosis, and the comparison of quantitative FA-parameters between arterial and venous ischemia. .	—

Contacts

Public ContactHanneke Joosten

Amsterdam UMC

j.j.joosten@amsterdamumc.nl0651338913

Outcome results